MIS BondBone

GUDID 07290108990089

Bond Bone samples for professional use

MIS Implants Technologies Ltd.

Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft

• Primary Device ID: 07290108990089
• NIH Device Record Key: 217611b4-adee-471b-9de3-d1d92005cebb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIS BondBone
• Version Model Number: BS-BBSMP
• Company DUNS: 514576057
• Company Name: MIS Implants Technologies Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290108990089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101014

FDA Product Code

• LYC: Bone Grafting Material, Synthetic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-03
• Device Publish Date: 2021-07-26

On-Brand Devices [MIS BondBone]

• 07290108990072: BondBone 0.5cc Bonding-Graft Material
• 07290108990065: BondBone 1cc Bonding-Graft Material
• 07290108990089: Bond Bone samples for professional use